Electronic Cigarette Testing

EU TPD testing services

--EU TPD Directive on e-cigarette content detailed

  The EU Tobacco Directive TPD (2014/40/EU) came into force in May 2014, and the 2-year transition period has ended so far. EU member states will complete and implement the legal procedures related to the new directive in May this year. At that time, all new tobacco products entering the EU market will be controlled. Electronic cigarette products exported to the EU market must comply with the requirements of the TPD Directive, otherwise they will be banned, confiscated or returned, which will bring huge losses to electronic manufacturers.  Therefore, how to make electronic cigarette products comply with the EU TPD Directive to avoid losses has become a problem that manufacturers must face. This article explains in detail the issues related to electronic cigarettes in the TPD Directive.

First, the main content of the product electronic notice should contain

1. The name and contact information of the manufacturer

2. List of ingredients and release content

3. Toxicological data

4. Nicotine dose intake information

5. Product composition and description of the production process

6. Product quality and safety responsible for the statement

Second, the requirements of the tobacco oil and receptacle

Cigarette oil containing nicotine is placed on the market only in a professional filler, and the volume of the filler container does not exceed 10mL, in disposable e-cigarettes or single-use cartridges.

Cigarette or single-use cartridge, the volume of the cartridge or receptacle shall not exceed 2ml.

III. Nicotine related requirements

1. the nicotine content of the nicotine oil shall not exceed 20mg/ml;

2. under normal conditions of use, the nicotine release from the e-cigarette should be maintained at a stable level.

Four, registration process overview (EU TPD)

1. Registration (ECAS) Website:

https://webgate.ec.europa.eu/cas/eim/external/register.cgi

2. Apply for Submitter ID

2.1 Fill out the form submitted_egisttatingform_en.

2.2 Submit the form submitted_egisttatingform_en and wait for the EU Submitter ID to be assigned (about 10 working days to complete)

3. Notify the administrator by email after the registration is completed, stating that the ID registration is successful, with the ECAS and Submitter ID.

4. After the success, login to the account opening information platform (EU-CEG) to fill in the information, upload attachments, and select different countries to provide information separately.

U.S. FDA Testing and Registration Services

  On May 10, 2016, FDA (U.S. Drug Enforcement Administration) issued the final regulation Deeming Regulation, which came into effect on August 8, 2016, will include all electronic atomization products into the scope of tobacco products, through the regulation, FDA can legally regulate new tobacco products, including ENDS (Electronic Nicotine Deliver Systems), regulations on the production, importation, packaging, labeling, advertising, promotion, sales and other new tobacco products to make a series of provisions, products containing nicotine or products that may be used with nicotine are subject to FDA regulation, the regulatory object not only includes ENDS finished products, but also includes parts and components, but does not include accessories. Therefore, all electronic atomized products, including e-cigarettes, must comply with the requirements of the FDA Tobacco Control Act, and manufacturers need to comply with the compliance requirements.

I. Manufacturing site registration and product listings

1. registration and product listings apply only to manufacturers whose manufacturing activities occur within the United States;

2. Chinese manufacturers are not required to submit manufacturing site registrations as well as product lists to the FDA;

3. definition of manufacturing: any person, including any repackager or relabeler, who produces, manufactures, assembles, processes, or packages tobacco products, or imports finished tobacco products for sale or distribution in the United States;

4. time point.

5. businesses existing prior to August 8, 2016 that continue to engage in the manufacture of ENDS products must complete site registration and uploading of the product list by October 12, 2017, and update that list by June 30, 2018, and complete registration for the next ーyear by December 31, 2018;

6. Newly established manufacturers of ENDS products after August 8, 2016 must immediately complete the registration of production sites and the submission of the product list.

Second, health document submission

1. health documentation broadly includes documentation related to the health, toxicological, behavioral, or physiological effects of current or future tobacco products and their components (including smoke components), ingredients, components, and additives;

2. may include analytical test reports, studies, etc. conducted on the product, but not studies in the published literature that were not done for a specific product;

3. timeline:Health documentation prepared for products marketed before August 8, 2016 must be submitted to the FDA by the following dates:

3.1. large manufacturers - February 8, 2017

3.2. Small manufacturers-November 8, 2017  

4. Submission method: eSubmitter and CTP system

(http://ctpportal.fda.gov/ctpportal/login.jsp)

III. Ingredient List Submission

1. applicable to all products marketed in the United States, not limited to products registered in the United States;

2. Each ingredient must be individually identifiable.

3. the type of ingredients may include single chemical substances, composite sourcing ingredients;

4. Time point

4.1. non-small-scale manufacturers that existed prior to August 8, 2016, to be submitted by November 8, 2018;

4.2. the deadline for small-scale manufacturers is May 8, 2018; (time is returned or not)

4.3. Newly launched products must be submitted 90 days before the product launch

5. Submission method:eSubmitter as well as CTP system

(https:/ctpporta.fda.gov/ctpportal/login.jsp)

IV. Hazardous and potentially hazardous substances report (HPHC)

1. Harmful and Potentially Hazardous Substances are any compounds present in ENDS products or their fumes that may cause direct or indirect harm to consumers;

2. time point.

2.1. November 8, 2019;

2.2. Products launched after November 8, 2019 need to be submitted 90 days prior to launch.

3. Submission method: eSubmitter as well as CTP system

(https:/ctpporta.fda.gov/ctpportal/login.jsp)

V. Market Access Application (PMTA)

1. e-cigarettes marketed before August 8, 2016 must submit a PMTA by August 8, 2022.

2. Must demonstrate that the product is suitable for the protection of public health.

3. Submit scientific studies and analyses related to the product

3.1. Product analysis;

3.1.2. product performance, such as dimensions, description of the overall structure, involving features, etc;

3.1.3. principles of operation, complete description of the way consumers use the product;

3.1.4. description of the entire product production process;

3.2. components, ingredients, additives;

3.2. health studies;

3.2.1. clinical studies;

3.2.2. consumer perception data;

3.2.3. Usage data;

3.2.4. human factors;

3.2.5. non-clinical studies of liability for abuse;

3.2.6. scientific literature reviews.

VI. Services we can provide

  Lixun Testing is one of the early independent third-party testing organizations for e-cigarette testing in China, with a strong technical research and development team, equipped with advanced testing instruments. We maintain good cooperation with the most influential e-cigarette brands in the world. Our testing methods for e-cigarette oil and smoke have been approved by China National Accreditation Service for Conformity Assessment (CNAS), and the reports issued are widely recognized and well received internationally.

We can provide the following testing services for our customers:

1. assistance in the registration of production sites and product lists;

2. health and stability production and submission

3. ingredient list registration

4. Hazardous and potentially hazardous substances (HPHC) testing and report submission;

5. assistance with market access applications (PMTA).

Electronic cigarette UAE certification

I. What is ECAS certification?

  The Emirates Standards Authority (ESMA) was established under the UAE Federal Law No. 28 of 2001 (UAE Federal Law (28), 2001) and is the only national standards body and certification body in the UAE. In order to effectively implement the UAE national standards, ESMA's Conformity Assessment Department implements a product safety certification system, referred to as the Emirate Conformity Certification Scheme (Emirate).