UK compliance requirements for e-cigarettes

background

On 26 February 2014, the European Parliament formally approved the Tobacco and related products DIRECTIVE(2014/40/EU) as amended, which replaces Directive 2001/37/EC. It is customary to call 2001/37/EC TPD I and 2014/40/EU TPD II. The 2014/40/EU, which came into force on 20 May 2016, includes electronic atomizers within the scope of the Tobacco Products Directive for the first time. Chapter 20 clearly puts forward requirements for the marketing of electronic atomizer products, requires the products to be registered 6 months before the market, and describes in detail 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 31 December 2020, the UK's Brexit transition period ended, and the UK's TPD began to operate entirely on its own system.

Although Northern Ireland is part of the United Kingdom, its rules and regulations still comply with the requirements of the European Union.

On 17 December 2020, the European Commission announced that it would bring the Northern Ireland Protocol into force; After several delays, the document entered into force on 30 June 2021. According to the document, goods shipped to Northern Ireland from the rest of the UK will have to be checked under EU rules as the country remains in the EU customs union and single market after Brexit.

Test requirement

Test the content of the following chemical substances in the smoke released by the electronic atomizer, the first 3 items in the test of products without fume oil, and all 7 items in the test of products with fume oil

Registration process

1. Register MHRA Protal account and obtain company number

2. Collect basic product information, production process documents, fume adding instructions for atomizer, smoke test report, product composition information, component CLP grading and TOX information, assign different EC-ids to different products, and submit registration information through MHRA Protal

3. UK MHRA receives the registration document, sends the INVOICE to the applicant, the applicant pays according to the INVOCIE requirements, waits for the audit result and publishes it

2. The British representative

The TPD directive explicitly states that manufacturers outside the UK selling e-cigarette products in the UK must appoint a natural or legal person within the UK as their representative.

1. The British representative must be a natural or legal person in the United Kingdom

2. The UK representative must be authorised by the manufacturer

3. Duties of the British Representative:

a. Check the technical documentation and conformance statement of the product to ensure compliance with the requirements of the relevant UK regulations and harmonized standards

b) Provide the necessary information and documents to the market supervision authority in a timely manner if necessary

c) If the product is known to involve certain risks, it should take the initiative to report to the market supervision authority

d) Ensure that necessary corrective actions are taken immediately in case of product problems

4. UK Representative's information: Name or company name or registered trademark, contact information, mailing address must appear on the product or packaging, package or accompanying documents

3. FCM(Food Contact Material)

The oil storage bin of the electronic atomizer is in contact with the oil of the electronic atomizer for a long time, and then the smoke oil will be atomized and inhaled by consumers. Therefore, the materials in the oil storage bin that are in contact with the smoke oil should meet the standard requirements of food contact materials.

The UK still uses EU Regulation (EC)No 1935/2004

4. UKCA

It is a compulsory certification to enter the UK market. Not all products need UKCA logo to enter the UK. At present, the UK only stipulates that the products listed in the link below need to meet the requirements of UKCA.

https://www.gov.uk/guidance/using-the-ukca-marking

In general, electronic atomizer products need to comply with the RoHs Directive and the EMC Directive in order to display the UKCA logo. Of course, if the product has other features or accessories, it may also need to comply with other directives.

For example, if you have wifi or Bluetooth, you need to comply with the RED directive. If you have a power adapter, you need to comply with the LVD directive.

5. Clp-psn-ufi-sds (refer to EU requirements)

PCN-UFI

On 31 August 2020, the European Union published (EU) 2020/1677, amending CLP Regulation (EC) No 1272/2008. The main purpose of this amendment is to Improve the operability of information requests related to emergency health responses. .

CLP=The Classification, Labelling and Packaging

PCN=Poison Center Notification

UFI=Unique Formula Identifier(UFI)

E-cigarettes are classified as health or bodily hazard products and need 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 EU's CLP Regulation (EC No 1272/2008), which came into force on 20 January 2009, deals with the classification, labelling and packaging of substances and mixtures. The CLP regulation incorporates the standards of the United Nations Uniform Global System for the Classification and Labelling of Chemicals (GHS) and is complementary to 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 the SDS requirements of the REACH Regulation (1907/2006/EC) in order to ensure that their products comply with the EU required market.

Batteries and vaping fluids in e-cigarette products are CLP-regulated mixtures and are required to comply with the SDS requirements of the CLP Regulations.

6. REACH (refer to EU requirements)

SVHC

Highly focused on the substance of the candidate authorization list

https://echa.europa.eu/candidate-list-table

Appendix XVII

REACH restricted substance

https://echa.europa.eu/substances-restricted-under-reach

7. Battery Directive (refer to EU requirements)

Directive 2006/66/EC on Batteries and accumulators and Waste batteries and accumulators, which sets limits on the content of lead, cadmium and mercury in batteries, as well as detailed specification requirements for the labelling of batteries.

8. Battery safety IEC/EN62133 (refer to EU requirements)

62133 specifies safety requirements for portable sealed secondary cells or batteries (excluding button batteries) containing alkaline or non-acidic electrolytes for intended use or reasonably foreseeable misuse.

9. Packaging Directive 94/62/EC (reference to EU requirements)

The maximum permissible limit for harmful heavy metals (lead, chromium, mercury and hexavalent chromium) set out in Article 11 of Directive 94/62/EC is 100 mg/kg, with the aim of protecting underground water sources and soils. The scope of implementation covers all packaging and packaging materials.

10. The battery is UN38.3

According to IATA's Lithium Battery Transport Guidelines, lithium batteries for e-cigarettes are classified as Category 9 dangerous goods, and all lithium batteries or products containing lithium batteries that need to be transported by air must pass UN38.3.