Compliance requirements for e-cigarettes in the European Union

TPD

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 e-cigarettes in the Tobacco Products Directive for the first time. Chapter 20 clearly puts forward requirements for the marketing of e-cigarette products, requiring the products to be registered 6 months before the launch of the market, and describes in detail the list of materials to be submitted for registration. The TPD is an EU directive for the implementation of EU member States, which requires them to transpose it into their national law and implement it by 20 May 2016. When it comes to transposing an EU directive into the domestic law of an EU member state, there are slight differences in national laws and therefore different requirements. Before exporting products to the EU, the legal requirements of the destination country should be understood in detail to avoid non-compliance.

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 the EU Login account, submit the Submitter ID application form, and obtain the Submitter ID of the company

2. Collect basic product information, production process files, fume adding instructions for atomizer, smoke test reports, product composition information, CLP classification of components, and TOX information, assign different EC-ids to different products, and use XML tool to generate XML files

3. Submit the generated XML file through the EU-CEG system

4. Each member receives the registration document, sends an INVOICE to the applicant, who pays according to the INVOCIE requirements, waits for the audit result and makes it public

2. European Union representative

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

1. The EU representative must be a natural or legal person in the EU

2. The EU representative must be authorized by the manufacturer

3. Duties of EU Representatives:

a. Check the technical documentation and conformance declaration of products to ensure compliance with the requirements of relevant EU 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. Eu Representative's information: name or company name or registered trademark, contact information, mailing address must appear on the product or package, package or accompanying document

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.

European Union (EC)No 1935/2004

Applicable to EU member states that do not yet have corresponding food grade regulations

Member States may adopt and formulate their own food grade regulations in accordance with the requirements of this Regulation

German LFGB

German food and household products code

Section 30 - Prohibition on the protection of health: the placing on the market of any commodity containing hazardous materials harmful to human health is prohibited

Section 31 - Removal of substances: The transfer into food of materials containing substances harmful to human health or affecting the smell and taste of food is prohibited

Section 33 - Prevention of Deception: Materials or products are prohibited from being placed on the market if advertising, labelling, etc., misleads consumers

French DGCCRF

French Decree 2007-766 (same requirement as (EC) No 1935/2004)

For materials not covered by the above regulations, refer to DGCCRF 2004-64, whose requirements are mainly for: aluminium, stainless steel, steel with or without coating, paper and board, silicone, rubber, wood, etc

4. CE

It is a compulsory certification for entering the European Union market. Not all products need CE marking when entering the European Union. Currently, the European Union only stipulates that the products listed in the following links need to meet the CE requirements.

https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en

In general, e-cigarette products need to comply with the RoHs directive and the EMC directive before they can be labeled with the CE label. 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-PCN-UFI-SDS

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)

Electronic nebulizer fume oil is a health or bodily 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 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

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 command

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

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

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.