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Consumer Product Testing/Notification Services - Electronic Cigarette Special Section
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EU TPD
On April 2014, 4, the European Parliament and the Council of the European Union adopted Directive 3/2014/EU "On the harmonization of laws, regulations and administrative provisions of member states on the production, description and sale of tobacco and related products", according to Article 40 of Section 20 of Part III of the Directive, electronic cigarette products should be subject to notification requirements before they are marketed. Manufacturers and importers of e-cigarettes and liquid containers should:
Submit a notification to the competent authorities of the Member State in which they want to place such products on the market, in electronic form 2 months before the product is placed on the market, and a new notification whenever there is a material change in the product, through the EU-CEG XML Creator.
UK MHRA The UK Tobacco and Related Products Regulation (TRPR) is the translation of the EU TPD Directive, which is regulated and implemented by the UK Medicines and Healthcare Products Agency (MHRA
). From January 2021, 1, the United Kingdom officially left the European Union, and its e-cigarette notices were transferred to the official website of the UK Medicines and Healthcare Products Agency (MHRA), and manufacturers of new e-cigarette and filled container products must submit a notice to the MHRA 1 months before they intend to place their products on the Great Britain (GB) market.
U.S. PMTA
Under Section 910(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act, tobacco products should submit a pre-marketing application to the U.S. Food and Drug Administration (FDA) before they are marketed, seeking marketing orders administered by the U.S. FDA. In May 2016, FDA published 5 FR 81 in the Federal Register announcing the final rule for the regulation of e-cigarettes as tobacco products. In June 28973, FDA issued PMTA guidance 2019 FR 6 for ENDS products, which recommends that e-cigarette products require submissions. From September 84, 27200, e-cigarette products need to be submitted and passed the PMTA before they can be marketed.
HARP
, New Zealand, August 2021, 8, New Zealand published in its Official Gazette the Smoke-Free Environment and Regulated Products Regulations 10/2021 204, which replaced the Smoke-Free Environment Regulations 2021 and came into effect the day after its publication, with the New Zealand Ministry of Health responsible for the regulation and enforcement of the Regulations. The new parts 2017 and 5 and Schedule 6 of the regulation specify specific requirements for electronic cigarette product packaging, prohibited features, information display, notice, and product safety.
From 5 August 2021, manufacturers and importers located in New Zealand can notify e-cigarettes and smokeless tobacco products that they plan to or have entered the New Zealand market through the Health Advisory and Regulation Platform (HARP) of the New Zealand Ministry of Health; Products that have entered the New Zealand market must complete the notification by 8 February 11.
Saudi e-cigarette control In 2021, Saudi Arabia fully implemented the e-cigarette control norms, and the country's control of e-cigarette products is divided into two parts of the requirements for cigarette equipment and e-cigarette liquid: among them, cigarette equipment is regulated by the Saudi Organization for Standards, Metrology and Quality (SASO) published in its government gazette on November 2019,
11 - "Electronic Devices Used in Electronic Smoking Systems"; The e-cigarette liquid is regulated by the Technical Regulation (TR) "Electronic cigarette liquid and heated tobacco used in e-smoking systems" adopted by the Ministry of Food under the Saudi Food and Drug Administration (SFDA) on July 1, 2020 by Resolution 7/20-11-7.
UAE ECAS In April 2019, the UAE Authority for Standardization and Metrology (ESMA) issued and came into effect the mandatory standard UAE.S 4:5030 for electronic nicotine products, which became the first UAE technical regulation for the control of electronic nicotine products, requiring that before the product is marketed, the manufacturer or importer must submit a notification to ESMA and obtain an ECAS
certificate, otherwise it is not allowed to be imported in the UAE market. Manufacturing or putting on products.
In July 2018, ESMA, together with the Office of the Secretary of State for Advanced Technologies and the Department of Energy and Infrastructure Industry, was merged into the newly created Ministry of Industry and Advanced Technologies (MoIAT), to which the e-service for e-cigarette product compliance previously conducted on the ESMA website was also transferred to the MoIAT website.
China's Policy Outlook On November 2021,
11, the State Council promulgated the Decision on Amending the Regulations for the Implementation of the Tobacco Monopoly Law of the People's Republic of China and officially came into effect, which specifies that "new tobacco products such as electronic cigarettes shall be implemented with reference to the relevant provisions of these Regulations on cigarettes".
On November 10, the State Tobacco Monopoly Administration issued a notice on soliciting opinions on the national standard (draft for comments) of "Electronic Cigarettes".
On December 11, the State Tobacco Monopoly Administration responded to the regulatory issue of new tobacco products such as electronic cigarettes, and the products included in the scope of supervision include electronic cigarette cartridges, cigarette utensils and products sold in combination with cigarette cartridges, nicotine for e-cigarettes, etc. A series of national plans and policies mean that China's e-cigarette control is about to enter a new normal.
Obligations related to enterprises
With the gradual implementation of the provisions of e-cigarette control regulations in various countries, e-cigarette manufacturers interested in domestic and overseas markets should earnestly fulfill their e-cigarette product quality compliance and notification obligations, understand the relevant regulatory control requirements of the country as soon as possible, and prepare the documents and materials required for notification in a timely manner for use by relevant parties in the supply chain.
LCS Service Luxshare Testing
has professional e-cigarette compliance services and product testing capabilities, providing customers with one-stop services for e-cigarette testing, certification and notification.
Electronic cigarette equipment finished products and accessories CB testing services IEC
60335-1, IEC 60335-2-29, IEC 62133-2, etc.
Electronic cigarette set/liquid / smoke harmful substance testing service Specific
harmful substances such as: nicotine, alcohols, aldehydes and ketones, acyls, nitrosamines, trace metals, VOCs, etc.;
Specific regulatory requirements such as: TPD, SASO, ECAS, RoHS, REACH, FCM, etc.;
Other testing requirements specified by retailers and brands.
Electronic cigarette export notification and certification services EU
TPD notice, UK MHRA notice, New Zealand HARP notice, EU CE certification, US FCC certification, etc.
E-cigarette regulation training services Interpretation
of e-cigarette regulations and control requirements such as the EU TPD, the UK MHRA, the New Zealand HARP, the US PMTA, the UAE ECAS, and the Saudi SASO.
备注：
TPD: Tobacco Product Directive
TRPR: Tobacco and related Products Regulations
MHRA: Medicines and healthcare products regulatory agency
PMTA: Premarket Tobacco Product Application
FD&C: Federal Food, Drug, and Cosmetic Act
FDA: Food and Drug Administration
HARP: Health Advisory and Regulatory Platform
SASO: Saudi Arabian Standards Organization
SFDA: Saudi Food & Drug Authority
TR: Technical regulation
ECAS: Emirates Conformity Assessment Scheme
MoIAT：Ministry of Industry and Advanced Technology
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