SMOORE Announces China’s First Corporate Risk Assessment Laboratory for the European Union Tobacco Products Directive Compliance
March 11, 2022, Shenzhen, China—SMOORE, a global leader in offering vaping technology solutions, today announced an industry-leading risk assessment laboratory for the European Union Tobacco Product Directive (EUTPD) compliance. Thus, SMOORE has become China’s first company capable of providing vaping products with one-stop TPD risk assessment service. Belonging to SMOORE fundamental research center, the laboratory will be a hub to empower more vaping brands to comply with the safety standards of EUTPD, thereby meeting the EU vaping market entry requirements.
This laboratory has begun operation in the first half of 2021, and already completed 52 product tests for several world-leading vape brands. As China’s first corporate TPD-compliant risk assessment laboratory, it can generate test reports within 5 working days. Its laboratory equipment is benchmarked against those in world-class analytical testing laboratories, such as Labstat and Enthalpy.
Entering into force in 2014, the TPD is a unified directive for tobacco regulations in the 27 EU Member States. It regulates the sale, presentation and manufacture of all tobacco products, including e-cigarettes, in the EU. For the sake of quality control and public health protection, the TPD sets specific safety requirements for the content of e-cigarettes, such as nicotine concentration, heavy metals, carbonyl, Aldehydes and Ketones, for the products allowed to be placed on the EU market.
As the second largest market for vaping products after North America, Europe has over 16.74 million adult vapors in 2022, with a market size of USD 5.58 billion (ECigIntelligence). Furthermore, the regional vaping market size is projected to witness a CAGR of 13.17% in the next 6 years.
With only one e-cigarette (Vuse Solo) approved by the U.S. FDA through the Premarket Tobacco Product Application (PMTA) pathway so far, more and more vape brands are aiming for European market, considering its relatively friendly regulatory environment and significant market potential.
As the industry’s harm reduction and quality benchmark, SMOORE complies with its in-house SMOORE 3.0 safety standards. Based on the risk assessment guidance of U.S. EPA (Environmental Protection Agency) and PMTA, SMOORE 3.0 covers all of the PMTA vapor safety tests and HPHCs (Harmful and Potentially Harmful Constituents) listed by U.S.FDA. In addition to vapor safety, SMOORE 3.0 also involves extractable and leachable substances of medical-grade atomization materials.
SMOORE fundamental research center has developed a comprehensive analytical testing and risk assessment system, covering PMTA non-clinical testing and health risk assessment. Accredited by China National Accreditation Service for Conformity Assessment(CNAS) in 2019, now it is capable of up to 149 CNAS tests, involving the chemical analysis of e-liquids and aerosols, electrical safety, material safety and battery safety.
Since FEELM, the flagship atomization tech brand belonging to SMOORE, entered the EU market in 2018, SMOORE has been in partnership with several leading vape brands in this region, including Vuse, HEXA, Innocigs and Alfapod. To date, vaping products loaded with FEELM technologies have been exported to Belgium, Netherlands, Estonia, and Romania, with market leadership in the UK, Germany and France.