E-LIQUIDS COMPLIANCE SERVICES
Discover the e-liquids compliance services to meet the regulations governing the marketing of e-liquid in the Member States of the European Union:
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;
- Analysis of emissions and consistency of nicotine release;
- 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;
- Inclusion of the CLP classification of the mixture (we can also supply you with the assessment of the accuracy of the given classification, considering the complete formulation of the product and with the correction);
- 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, quali-quantitative formula, weights and volumes, …;
- For each ingredient of the formulation, entering of: name and identification code, toxicological status, REACH position, CLP classification, assessment through toxicological reports made by our scientific team coordinated by a toxicologist with RENTIC (National Register of Certified Italian Toxicologists) and ERT ( The European Register of Toxicologists) qualifications;
- 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;
- Issue and 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 States.
CHEMICAL ANALYSIS OF EMISSIONS
Mandatory under Directive 2014/40/EU TPD-II [Art. 20(2)(b)].
The analysis include 23 chemical parameters, comprising the 21 parameters listed by the European Commission in accordance with EU Implementation Order 2015/2183 of 24 November 2015.
Emission analysis is performed on each single aromatic variant and involves the production of aerosols by T-TRAP ™ (TRUSTICERT, Milan) vaping machine, built conforming to ISO/DIS 20768 standard.
To avoid additional requests from the authorities we suggest performing the complete analysis set, but it’s possible for us configure the parameter combinations you desire.
If your main market is UK, we suggest you follow the MHRA guidelines.
The analyses available are:
- nicotine (L-nicotine);
- glycols (ethylene glycol and diethylene glycol);
- aldehydes (butyraldehyde, isobutyraldehyde, propionaldehyde, formaldehyde, acetaldehyde, acrolein, crotonaldehyde);
- nitrosamines (TSNA: NNN, TSNA: NNK);
- heavy metals (arsenic, cadmium, chromium, copper, lead, nickel);
- volatile organic compounds – VOCs (toluene, benzene, 1,3-butadiene, isoprene, diacetyl, 2,3-pentadione).
The analysis are carried out by an accredited laboratory, according to UNI CEI EN ISO/IEC 17025: 2005 standard.
TOXICOLOGICAL ANALYSIS OF EMISSIONS
Analysis in support of the Declaration of Security required by Directive 2014/40/EU TPD-II [Art. 20(2)(g)].
Thanks to an investment made in advance of market demands, TRUSTiCERT is able to offer a technological set-up to assess the toxicity of vaporized substances or mixtures (with or without nicotine).
Toxicological tests are available on different cell lines:
- cytotoxicity test on murine fibroblast; *
- cytotoxicity test on human fibroblast;
- cytotoxicity test human lung epithelium;
- additional Endpoint: Measurement of one or more inflammatory mediators;
- endocrine disorder test on amphibian embryo.*
*Test performed by an accredited laboratory, according to UNI CEI EN ISO/IEC 17025: 2005 standard.
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.
TITRATION OF NICOTINE ON LIQUID
Mandatory under Directive 2014/40/EU TPD-II [Art. 20(3)(b), (f)].
Liquid nicotine concentration analysis is used to compile the relevant dose (nicotine dose uptake) required in the notification stage and provides a valuable reference to verify the quality of production through an external supplier.
The test is carried out by an accredited laboratory, according to UNI CEI EN ISO/IEC 17025: 2005 standard.
CONTAMINANT ANALYSIS IN LIQUID
Analysis in support of the Safe Product Declaration required by Directive 2014/40/EU TPD-II [Art. 20(2)(g)].
These types of analysis are not required by the TPD-II, but provide data in support of the non-hazard statement made during notification.
They also help supporting commercial claims (eg diacetyl free), that are becoming more and more important for the the final consumer.
The analyses available are:
- test of presence of diacetyl (CAS 431-03-8) and ethylene glycol (CAS 107-21-1);
- caffeine and taurine presence test;
- heavy metals measurement test (arsenic, cadmium, mercury, lead, antimony);
- measurement test for formaldehyde, acrolein and acetaldehyde.
Test performed by an accredited laboratory, according to UNI CEI EN ISO/IEC 17025: 2005 standard.
Analysis to predict chemical-physical and biological properties of chemical compounds which are lack of experimental data.
Experimental data gaps are common features in the chemical world. Our bioinformatic experts can predict (eco)toxicological endpoints and chemical-physical properties by using in silico methods (e.g. QSAR and Read-Across): learn more.
In silico methods are accepted and suggested by many regulatory authorities (e.g. FDA, Health Canada and ECHA) as a preliminary step to identify potential hazards for human health and to prioritize chemical substances.
Predicted endpoints are:
- Chemical-Physical Properties (i.e Melting/freezing point, Boiling point);
- Environmental Fate endpoints (i.e. Ready biodegradability);
- Ecotoxicological endpoints (i.e. Short- and/or log-term toxicity to fish);
- Toxicological endpoints (i.e. In vitro gene mutation in bacteria (Ames test), Skin irritation or skin corrosion, Skin sensitisation).
The service can be customized developing new QSAR models.
All analyzes are conducted following the ECHA and OECD guidelines.
Compliant with CLP Regulation (EC) No 1272/2008.
The CLP classification realized in function of the complete formulation (including the flavouring ingredients) submitted in the notification, is fundamental to ensure consistency between the hazard classification of the mixture and its composition, as stated in the notification.
It is also necessary to make compliant labeling, for the compulsory Safety Data Sheet, and to register the products at each national Poison Center.
SAFETY DATA SHEETS – SDS
In compliance with Reach Regulation (EC) No 1907/2006 and subsequent modifications.
The SDS is a legally binding informative document, the product supplier (manufacturer/importer/responsible company) must deliver to distributors or retailers (not to final users) when shipping the goods.
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.
REGISTRATION AT DANGEROUS PREPARATIONS ARCHIVES
Mandatory under CLP Regulation (EC) No 1272/2008.
Member States require the registration of vaping products in each national Poison Center that differ for procedure to be followed, requirements and costs.
You will be provided with a dedicated expert who, thanks to a network of European partners , will complete the bureaucratic procedures specific for each State.
Any requests for confidential data will be in advance evaluated, in accordance with the non-disclosure agreement we have signed.
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, the CLP Regulation, the Consumption Code.
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.