TPD background
On February 26, 2014, the European Parliament officially approved the revised tobacco products directive (2014 / 40 / EU), replacing the old Directive 2001 / 37 / EC. People used to call 2001 / 37 / EC TPD I and 2014 / 40 / EU TPD II. 2014 / 40 / EU has officially entered into force on May 20, 2016, and it has included e-cigarettes into the control scope of the tobacco product directive for the first time. Article 20 clearly puts forward requirements for the marketing of electronic cigarette products, requires the products to submit registration 6 months before listing, and specifies the list of materials to be submitted for registration. TPD is an EU directive, which is implemented by EU Member States. The Directive requires Member States to convert it into their domestic laws and implement it before May 20, 2016. When translating EU directives into the domestic laws of EU Member States, the laws of each country are slightly different, so there will be different requirements. Before exporting products to the EU, the legal requirements of the destination country shall be understood in detail to avoid non-compliance.
Test requirements
Test the content of the following chemicals in the smoke released by the electronic cigarette, excluding the first 3 items of the test for the products containing tobacco oil, and all 7 items of the test for the products containing tobacco oil
|
Serial number |
Category/classification
|
Test Items/Test items
|
1 |
Nicotine consistency/Stable nicotine release
|
Nicotine/Nicotine (test 5 sets of data and evaluate the stability of release) |
2 |
Carbonyl Compounds/Carbonyl compound
|
Formaldehyde/formaldehyde |
|
Acetaldehyde/acetaldehyde |
|
Acrolein/Acrolein |
|
crotonaldehyde/Butenal / Crotonaldehyde |
|
butyraldehyde/Butyraldehyde |
|
propionaldehyde/Propionaldehyde |
|
methyl ethl ketone/Methyl ethyl ketone |
|
acetone/acetone |
3 |
Trace Metals/Trace metals
|
Chromium/chromium |
|
Nickel/nickel |
|
Iron/iron |
|
Aluminum/aluminium |
|
Tin/tin |
|
Lead/lead |
|
Cadmium/cadmium |
|
arsenic/arsenic |
|
Antimony/antimony |
|
Copper/copper |
|
mercury/mercury |
4 |
Flavor/Acetyl
|
Diacetyl/Diacetyl |
|
Pentane 2,3 dione/acetyl |
5 |
Glycol/alcohols
|
Ethylene Glycol/glycol |
|
Diethylene Glycol/Diethylene glycol |
6 |
Tobacco-Specific Nitrosamines/Specific nitrosamines in tobacco
|
N-nitrosonornicotine (NNN) |
|
4-(N-methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) |
|
N-nitrosoanatabine (NAT) |
|
N-nitrosoanabasine (NAB) |
7 |
VOC substance
|
toluene/toluene |
|
benzene/benzene |
|
1.3-butadiene/1.3-butadiene |
|
isoprane/isoprene |
Registration process
-
Register the EU login account, submit the submitter ID application form, and obtain the submitter ID of the company
-
Collect basic product information, production process documents, instructions for adding smoke oil to atomizer, smoke test report, product composition information, composition CLP classification and tox information, assign different ec-ids to different products, and generate XML files using XML tool
-
Submit the generated XML file through eu-ceg system
-
After receiving the registration documents, each member state will send invoice to the applicant. The applicant will pay according to the requirements of invoice and wait for the review results to be published
EU representative
The TPD directive clearly mentions that when manufacturers outside the EU sell e-cigarette products in the EU, they must appoint natural or legal persons within the EU as their representatives.
1. The EU representative must be a natural or legal person within the EU
2. The EU representative must be authorized by the manufacturer
3. Responsibilities of EU representatives:
a. Check the technical documents and conformity statements of products to ensure compliance with the requirements of relevant EU regulations and harmonized standards
b. If required by market supervision institutions, necessary information and documents shall be provided to them in a timely manner
c. If you know that the product involves some risks, you should take the initiative to report to the market supervision authority
d. In case of product problems, ensure that necessary corrective measures are taken immediately
4. Information of EU representative: name or company name or registered trademark, contact information and mailing address must be reflected on the product or package, package or attached documents
FCM
EU 1935 / 2004 / EC
Germany lfgb
France DGCCRF
CE
RoHS
EMC
CLP-PCN-UFI
REACH SVHC
Reach appendix XVII
Battery command
Battery safety IEC62133
Packaging instruction
SDS
UN38.3 battery
UN38.3 bituminous oil
