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INFORMATION FOR UNIT PACKETS AND ANY OUTSIDE PACKAGING OF ELECTRONIC CIGARETTES AND REFILL CONTAINERS

From TPD (Art. 20):

(b) unit packets and any outside packaging of electronic cigarettes and refill containers:
(i) include a list of all ingredients contained in the product in descending order of the weight, and an indication of the nicotine content of the product and the delivery per dose, the batch number and a recommendation to keep the product out of reach of children;
(ii) without prejudice to point (i) of this point, do not include elements or features referred to in Article 13, with the exception of Article 13(1)(a) and (c) concerning information on the nicotine content and on flavourings; and
(iii) carry one of the following health warnings:
‘This product contains nicotine which is a highly addictive substance. It is not recommended for use by non- smokers’.
or
‘This product contains nicotine which is a highly addictive substance.’
Member States shall determine which of these health warnings is to be used;

(c) health warnings comply with the requirements specified in Article 12(2).

 

Overall requirements

- Dimensions if possible at least 52x74mm
- It shall be written in the official language(s) of the Member State(s) where the substance or mixture is placed on the market (unless the Member State(s) concerned provide(s) otherwise)
- Suppliers may use more languages on their labels than those required by the Member States

Packaging

pack_nov

1. Commercial name of the products

Also shall be added:
- The term «e-liquid»
- The product volume in mL

2. Nicotine

- The nicotine concentration shall be expressed in mg/mL or the words «nicotine free» (if < 0.5 mg/mL)
- An indication of the delivery per dose

3. Health warnings

- They appear on the two largest surfaces of the unit packet and any outside packaging
- They cover 30 % of the surfaces.(That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with more than two official languages)

4. Batch Number

- The name, address and telephone number of the supplier(s)
- The nominal quantity of the substance or mixture in the package (unless this quantity is specified elsewhere in the package)
- Product identifiers
- The name of the natural or legal person responsible for bringing to market
- A website providing the product information leaflet
- A best-by date

5. List of all ingredients:

- They have to be declared in descending order of the weight; flavouring compounds have to be declared
- If the alcohol content is higher than or equal to 1.2°: the maximum level (<xx°) shall be mentioned
- The presence of food allergens «allergen(s):xxx»
- The PG/VG ratio expressed in weight to -weight of the diluent

6. Warning

- A recommendation to keep the product out of reach of children.
- Also “Do not swallow, avoid prolonged contact with the skin» shall be added

7. Where applicable

7.1 Hazard pictograms

- It must have a dimension between 10x10 and 16x16 mm
- It must cover at least 1/15 of the area of the label dedicated to obligatory labelling information, but must not be less than 1 cm2

7.2 Phrases P

- They shall indicate the label elements for each hazard class (tables in Parts 2 to 5 of Annex I)
- They shall be selected into account the hazard statements and the intended or identified use of the substance or mixture (Part 1 of Annex IV) (CLP 1272/2008)
-They shall be worded in accordance with Part 2 of Annex IV (CLP 1272/2008)

7.3 Others

- Signal words
- Phrases H
- Section for supplemental information

What we do to let a product become TPD2 compliant

in brief

1
GETTING TO KNOW YOUR COMPANY PROFILE AND PRODUCTS:

fulfillment of the dedicated form . Of course after having sign an NDA: you can trust us, but we want to be sure you’ll be. After that, you will receive our quote.

2
SUBMISSION OF SAMPLES TO BE ANALYZED AND PROFILING OF YOUR COMPANY IN THE EU-CEG PORTAL:

we will check that everything’s ok and then we will move forewords; we will get a Submitter ID on behalf of you.

3
TOXICOLOGICAL LITERATURE SEARCH

and issuing of a complete risk assessment report concerning every relevant ingredient of the blend. After that we will set up a testing solution suitable for your needs.

4
ANALYSIS OF THE EMISSIONS

and issuing of an analytical report. Parameters and conditions will be set as function of the type of products and markets.

5
COMPLIANCE

we will check every details to guarantee your product is compliant. If not, we will evaluate together how to proceed to obtain compliance.

6
PRODUCTION OF TECHNICAL DOSSIER.

through the integrated evaluation of information from manufacturer, analytical labs and from toxicological risk assessment.

7
SUBMISSION OF NOTIFICATION.

You will receive the EC-ID and you will be then ready to market your products in the European Union.