On February 26, 2014, the European Parliament officially approved the revised Tobacco and related products DIRECTIVE (2014/40/EU), which replaced the old version of Directive 2001/37/EC. It is called TPD I, and 2014/40/EU is called TPD II. 2014/40/EU came into effect on May 20, 2016, and for the first time included electronic cigarettes in the scope of the Tobacco Products Directive. Among them, Article 20 clearly puts forward requirements for the marketing and sales of electronic cigarette products, requires products to be submitted for registration 6 months before the market, and specifies the list of materials to be submitted for registration.
In 2016, the UK converted TPD into UK regulations The Tobacco and Related Products Regulations 2016 (TRPR)
On December 31, 2020, the Brexit transition period in the United Kingdom ended, and the British TPD began to operate entirely on its own system.
Although Northern Ireland belongs to the United Kingdom, the laws and regulations in the region still comply with the requirements of the European Union.
On December 17, 2020, the European Commission announced that it would bring the Northern Ireland Protocol into force; after several extensions, the document entered into force on June 30, 2021. According to the document, Northern Ireland will remain in the EU customs union and single market after Brexit, and goods shipped from the rest of the UK to Northern Ireland must be inspected under EU rules.
Test the content of the following chemical substances in the smoke released by electronic cigarettes, excluding the first 3 items of the e-liquid product test, and all 7 items of the e-liquid-containing product test
测试电子烟释放出的烟雾中下列化学物质的含量，不含烟油产品测试前3项，含烟油产品测试全部7项
|
number |
Category/分类 |
Test Items/测试项目 |
|
1 |
Nicotine consistency/尼古丁稳定释放 |
Nicotine/尼古丁(测试5组数据，并评估释放的稳定性) |
|
2 |
Carbonyl Compounds/羰基化合物 |
Formaldehyde/甲醛 |
|
Acetaldehyde/乙醛 |
|
Acrolein/丙烯醛 |
|
crotonaldehyde/丁烯醛/巴豆醛 |
|
butyraldehyde/丁醛 |
|
propionaldehyde/丙醛 |
|
methyl ethl ketone/甲乙酮 |
|
acetone/丙酮 |
|
3 |
Trace Metals/痕量金属 |
Chromium/铬 |
|
Nickel/镍 |
|
Iron/铁 |
|
Aluminum/铝 |
|
Tin/锡 |
|
Lead/铅 |
|
Cadmium/镉 |
|
arsenic/砷 |
|
Antimony/锑 |
|
Copper/铜 |
|
mercury/汞 |
|
4 |
Flavor/乙酰类 |
Diacetyl/二乙酰 |
|
Pentane 2,3 dione/乙酰 |
|
5 |
Glycol/醇类 |
Ethylene Glycol/乙二醇 |
|
Diethylene Glycol/二甘醇 |
|
6 |
Tobacco-Specific Nitrosamines/烟草中特有亚硝胺 |
N-nitrosonornicotine (NNN) |
|
4-(N-methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) |
|
N-nitrosoanatabine (NAT) |
|
N-nitrosoanabasine (NAB) |
|
7 |
VOC物质 |
toluene/甲苯 |
|
benzene/苯 |
|
1.3-butadiene/1.3-丁二烯 |
|
isoprane/异戊二烯 |
registration process
1. Register an MHRA Portal account and get a company number
2. Collect basic product information, production process documents, nebulizer adding e-liquid instructions, smoke test reports, product composition information, composition CLP classification and TOX information, assign different EC-IDs to different products, and pass the MHRA online portal MHRA Portal submits registration information
3. The UK MHRA receives the registration documents, sends INVOICE to the applicant, the applicant pays according to INVOCIE requirements, waits for the review result and announces it
2. UK representative
The TPD Directive clearly mentions that manufacturers outside the UK who sell electronic cigarette products in the UK must appoint a natural or legal person within the UK as their representative.
1. The UK representative must be a natural or legal person within the UK
2. The UK representative must be authorised by the manufacturer
3. Responsibilities of the UK Representative:
a, Check the technical documentation and declaration of conformity of the product to ensure compliance with relevant UK regulations and harmonized standards
b, if required by market surveillance agencies, they shall be provided with the necessary information and documents in a timely manner
c, If you know that the product involves certain risks, you should take the initiative to report to the market surveillance agency
d, When there is a problem with the product, ensure that the necessary corrective action is taken immediately
4. UK representative's information: name or company name or registered trademark, contact information, mailing address must be reflected on the product or packaging, package or accompanying documents
3. FCM (Food Contact Material)
The e-cigarette oil storage tank is in contact with the e-liquid for a long time, and then the e-liquid will be atomized and inhaled by consumers. Therefore, the materials in the oil storage tank that are in contact with the e-liquid need to meet the standard requirements of food contact materials.
The UK still follows EU Regulation (EC) No 1935/2004
4. UKCA
A compulsory certification for entering the UK market, not all products entering the UK need the UKCA logo. At present, the UK only stipulates that the products listed in the link below need to meet the UKCA requirements.
https://www.gov.uk/guidance/using-the-ukca-marking
Generally speaking, e-cigarette products need to comply with the RoHs directive and the EMC directive before they can post the UKCA logo. Of course, if the product has other functions or accessories, it may also need to comply with other directives.
For example, with wifi or bluetooth functions, it needs to comply with the RED directive, and with a power adapter, it needs to comply with the LVD directive.
5. CLP-PCN-UFI-SDS (refer to EU requirements)
PCN-UFI
On August 31, 2020, the European Union published (EU) 2020/1677 amending the CLP Regulation (EC) No 1272/2008, the main purpose of which was to "improve the operability of information requirements related to emergency health responses. ".
CLP=The Classification, Labelling and Packaging
PCN=Poison Center Notification
UFI=Unique Formula Identifier (unique formula identifier)
E-cigarette liquid is a health or physical hazard product and needs to meet the requirements of (EU) 2020/1677.
Please refer to the link below for specific requirements
http://www.element-testing.com/news/tradenews/63.html
SDS
The European Union's CLP Regulation (EC No 1272/2008) came into force on 20 January 2009 and deals with the classification, labelling and packaging of substances and mixtures. The CLP regulation incorporates the standards of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and complements the EU REACH regulation.
Manufacturers, importers, distributors and downstream users must ensure that their current and future Safety Data Sheets for Substances, Preparations and Mixtures comply with the CLP Regulation and REACH Regulation (1907/2006/EC) SDS requirements to ensure that their products meet EU market requirements .
Batteries and e-liquids in e-cigarette products belong to the mixture controlled by CLP and need to meet the requirements of CLP regulations on SDS.
6. REACH (refer to EU requirements)
SVHC
Candidate List for Authorization of Substances of Very High Concern
https://echa.europa.eu/candidate-list-table
Appendix XVII
REACH restricted substances
https://echa.europa.eu/substances-restricted-under-reach
7. Battery Directive (refer to EU requirements)
2006/66/EC Directive on batteries and accumulators and waste batteries and accumulators, which limits the content of lead, cadmium and mercury in batteries, and also has detailed specifications for the labeling of batteries.
8. Battery safety IEC/EN62133 (refer to EU requirements)
62133 specifies the safety requirements for portable, sealed secondary cells or batteries (excluding button cells) containing alkaline or non-acidic electrolytes for intended use or reasonably foreseeable misuse.
9. Packaging Directive 94/62/EC (refer to EU requirements)
Directive 94/62/EC Article 11 stipulates a maximum allowable limit of 100 mg/kg of harmful heavy metals (lead, chromium, mercury, hexavalent chromium), which aims to protect groundwater sources and soil. The scope of implementation covers all packaging and packaging materials.
10. Battery UN38.3
According to the "IATA Lithium Battery Transportation Guidelines", the lithium battery of the electronic cigarette belongs to the 9th category of dangerous goods. All lithium batteries or products containing lithium batteries that need to be transported by air must pass the UN38.3 test.
